JHF · Class II · 21 CFR 862.1455

FDA Product Code JHF: Colorimetric Method, Lecithin/sphingomyelin Ratio

Leading manufacturers include Isolab, Inc. and Abbott Laboratories.

2
Total
2
Cleared
282d
Avg days
1989
Since

FDA 510(k) Cleared Colorimetric Method, Lecithin/sphingomyelin Ratio Devices (Product Code JHF)

2 devices
1–2 of 2
Cleared Feb 08, 1995
TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II
K940817
Abbott Laboratories
Chemistry · 351d
Cleared Mar 15, 1989
PG-NUMERIC(TM)
K883411
Isolab, Inc.
Chemistry · 212d

About Product Code JHF - Regulatory Context